Regulatory

In early 2010, the FDA shocked investors in Cytori by refusing to grant a 510K on the Celution 800 device. A 510K approval would have granted Cytori the right to market the Celution system to doctors and hospitals as a device capable of providing a clinical grade dose of stem and regenerative cells for use in the practice of medicine (for use in any application the doctors felt was appropriate). By Congressional Charter, the FDA does not have authority over the practice of medicine. So, why was it a shock that the FDA refused to grant Cytori’s Celution System a 510K? The reason was because the medical device produced stem cells that were highly effective and therefore was worried the cells would be used too widely. As a precaution, the FDA wanted to regulate the Celution System as a biologic rather than a medical device. Safety is the responsibility of the FDA and because these stem cells had been demonstrated to be highly effective, the FDA ruled that each application must be approved based on clinical trial data.